The following data is part of a premarket notification filed by Merete Medical Gmbh with the FDA for Osteobridge Ika Knee Arthodesis Nail With Collar.
| Device ID | K120978 |
| 510k Number | K120978 |
| Device Name: | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Contact | Emmanuel Anapliotis |
| Correspondent | Emmanuel Anapliotis MERETE MEDICAL GMBH 102 ALT LANKWITZ Berlin, DE D-12247 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048266130983 | K120978 | 000 |
| 04048266130785 | K120978 | 000 |
| 04048266130792 | K120978 | 000 |
| 04048266130808 | K120978 | 000 |
| 04048266130815 | K120978 | 000 |
| 04048266130822 | K120978 | 000 |
| 04048266130839 | K120978 | 000 |
| 04048266130846 | K120978 | 000 |
| 04048266130907 | K120978 | 000 |
| 04048266130914 | K120978 | 000 |
| 04048266130921 | K120978 | 000 |
| 04048266130938 | K120978 | 000 |
| 04048266130945 | K120978 | 000 |
| 04048266130952 | K120978 | 000 |
| 04048266130969 | K120978 | 000 |
| 04048266130853 | K120978 | 000 |